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Cenerimod for Systemic Lupus Erythematosus (OPUS-1 Trial)
OPUS-1 Trial Summary
This trial will investigate if cenerimod is effective at reducing symptoms of SLE in adult patients with moderate to severe symptoms.
OPUS-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOPUS-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 1 & 2 trial • 105 Patients • NCT02472795OPUS-1 Trial Design
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- I haven't had B cell-depleting therapy in the last year.I have severe brain-related lupus symptoms.I have not taken certain medications recently.I am not pregnant, will test monthly, and will use effective birth control during and 6 months after the study.I have not taken specific medications before screening.My lupus is affecting at least two organs moderately or one organ severely.Your doctor rates your overall disease severity as moderate to severe.My lupus is active, with significant skin or joint symptoms.I was diagnosed with lupus more than 6 months ago.I am currently on medication for lupus.I have been diagnosed with mixed connective tissue disease or similar conditions.I have a history of specific heart, lung, blood, liver, eye, or cancer-related conditions.I am taking between 7.5 and 30 mg of prednisone daily for my lupus.
- Group 1: Matching placebo
- Group 2: Cenerimod 4 mg
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Cenerimod 4 mg met the requirements of the Food and Drug Administration?
"Cenerimod 4 mg is rated a 3 on our safety scale due to prior clinical evidence substantiating its efficacy, as well as the multiple sources of data that ensure its security."
Is the elderly population included in this experimental endeavor?
"For this study, the age requirement is between 18 and 75. There are 19 trials currently available for minors and 108 studies targeting elderly patients."
Is this trial presently recruiting new participants?
"Affirmative. According to the information provided on clinicaltrials.gov, this medical trial is in its recruitment phase with a requirement of 420 participants across two sites. It was first posted on December 13th 2022 and most recently updated on December 22nd 2022."
To what extent is the trial population engaged in this experiment?
"Affirmative. According to the clinicaltrials.gov database, enrollment for this medical research is ongoing since its initial launch on December 13th 2022 and latest update on December 22nd 2022. 420 participants are requested at two distinct sites."
What are the criteria for joining this experimental research program?
"This trial seeks to enrol 420 people that have been diagnosed with Libman-Sacks Disease and are aged 18 - 75. To qualify, participants must satisfy the following conditions: a Systemic Lupus Erythematosus (SLE) diagnosis for at least 6 months prior to screening; an elevated modified Systemic Lupus Erythematosus Disease Activity Index-2000 score of more than 6 points including 2 or more musculoskeletal/mucocutaneous manifestations; British Isles Lupus Assessment Group-2004 Grade B in at least two organ systems or one A grade system; Physician's Global Assessment"
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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